Bupropion for the treatment of nerve pain. A randomized, double-blind study.

Phase 1

• Conditions: Peripheral neuropathic , i.e. painful polyneuropathy, postherpetic neuralgia and pain after nerve injury (traumatic or surgical).; MedDRA version: 20.0Level: LLTClassification code 10077974Term: Peripheral neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-000243-27-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-28
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- age over 18 years
- peripheral neuropathic pain for more than 3 months
- pain score at least 4 and not higher than 9 on a numeric rating scale 0-10 points

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

- other significant pain that cannot be distinguised from the peripheral neuropathic pain
- significantly reduced liver and kidney function
- epilepsy or recurrent seizures
- known lowered seizure threshold or significant risk factors for seizures
- major depressive episode within 6 months or other significant psychiatric diseases including alcohol or drug abuse
- Important drug interactions (e.g. treatment with levo-dopa, amantadin, MAO-inhibitors, flecainide, risperidine, thioridazine)
- pregnancy or lactation
- known allergy to bupropion or exipients
- concomittant pain treatment with TCAs, SNRIs, opioids, topical analgesics (lidocaine, capsaicin) and cannabinoids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified